drugset / Trial / NCT00264186

Recombinant Human Superoxide Dismutase (rhSOD) and Vascular Reactivity

NCT00264186

RandomizedParallel-groupDouble-blind

Summary

Inflammation is characterised by an increased risk for cardiovascular events. Dysfunction of the vascular endothelium caused by oxidative stress might provide a mechanistic link. In acute and chronic inflammation, oxidative stress occurs when the production of reactive oxygen species \[ROS\] (including superoxide anions \[O2-\]) exceeds the capacity of the endogenous antioxidant defense systems, resulting in ROS-mediated damage. Recombinant human superoxide dismutase (rhSOD) has shown potent antioxidant properties in in-vitro and animal studies and has been tested in phase I clinical trials in humans. rhSOD could offer a therapeutic option for vascular dysfunction in diseases associated with increased oxidative stress. The investigators, therefore, want to test if the hyporesponsiveness to vasoactive drugs (norepinephrine, acetylcholine and glyceroltrinitrate) during acute inflammation by low-dose lipopolysaccharide (LPS) is due to the increased production of superoxide anions, which could be scavanged by the radical scavenger rhSOD.

Timeline

Start
2005-06
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetylcholine Small molecule 6.25 unknown Other
Subject Acetylcholine Small molecule 12.5 unknown Other
Subject Acetylcholine Small molecule 25 unknown Other
Subject Glyceroltrinitrate Unknown 4 unknown
Subject Glyceroltrinitrate Unknown 8 unknown
Subject Glyceroltrinitrate Unknown 16 unknown
Subject Norepinephrine Other / unclassified 60 unknown Other
Subject Norepinephrine Other / unclassified 120 unknown Other
Subject Norepinephrine Other / unclassified 240 unknown Other
Subject rhSOD Protein / enzyme biologic 82000 iu Other

Indications

No indication recorded.